1. Airflow & Air Velocity Test

•Purpose: To ensure airflow direction & speed meet design requirements.

•Example: Measuring velocity at terminal HEPA filters (m/s).

 

2. Air Changes per Hour (ACPH) Test

•Purpose: To verify required number of air changes per grade/room.

•Example: Grade B cleanroom requires ≥ 40–60 ACPH.

 

3. Differential Pressure Test

•Purpose: Confirms pressure cascade is maintained between rooms.

•Example: Grade B to Grade C room = ≥ 10–15 Pa difference.

 

4. HEPA Filter Integrity (DOP/PAO Test)

•Purpose: Ensures no leakage in filters.

•Example: Aerosol challenge test using PAO and scanning with photometer.

 

5. Airflow Visualization (Smoke Study)

•Purpose: Demonstrates unidirectional flow & no turbulence.

•Example: Smoke test around laminar airflow workstation (LAF).

 

6. Temperature & Relative Humidity Test

•Purpose: To confirm comfort & product protection.

•Example: Temp = 18–25 °C, RH = 45–55% for cleanrooms.

 

7. Non-Viable Particle Count Test (NVPC)

•Purpose: To verify compliance with ISO 14644 limits.

•Example: ISO Class 5 (Grade A) = max 3520 particles ≥ 0.5 µm / m³.

 

8. Viable Particle Monitoring (Microbial)

•Purpose: To check microbiological cleanliness.

•Example: Settle plates, air samplers (CFU/m³).

 

9. Recovery Test

•Purpose: To determine time for cleanroom to return to baseline after contamination.

•Example: From 100,000 particles to 3,520 particles within 15–20 minutes

 

Temperature Mapping (also called Thermal Mapping) is the systematic process of measuring, recording, and analyzing the temperature distribution within a storage area, equipment, or controlled environment to ensure that all locations maintain the required temperature range for product quality, safety, and regulatory compliance.

 

Purpose: Ensure controlled storage areas maintain the required temperature range for stability and product quality.

Examples:

•Raw Material Storage Room: 15–25°C

•Finished Goods Warehouse: 2–8°C (cold chain products)

•Quarantine Zones: Room temperature monitoring for incoming/outgoing materials

•Retain Sample/Control Sample Rooms: 2–8°C or 15–25°C depending on product type

 

Purpose: Verify equipment like incubators, ovens, and refrigerators maintain uniform temperature.

Examples:

•Laboratory Incubator: 37°C ± 0.5°C uniformity for microbial growth

•Cold Room / Refrigerator: 2–8°C with validated temperature sensors

•Lyophilizer Storage Area: -20°C ± 2°C for freeze-dried products

 

Purpose: Confirm uniform temperature distribution inside sterilizers to ensure effective sterilization.

Examples:

•Autoclaves (Steam Sterilizers): 121°C for 30 min cycle

•Dry Heat Sterilizers: 160–180°C depending on product and cycle

•Depyrogenation Tunnels: 250–300°C for endotoxin removal

 

Purpose: Ensure product integrity during transportation.

Examples:

•Vaccine Transport Boxes: 2–8°C monitored with data loggers

•Courier Shipment Validation: Temperature mapping for refrigerated transport